CancerNCT02753296
Development and Evaluation of a Fertility Preservation Patient Decision Aid for Women With Cancer.
An observational study of Cancer, run by University of Sheffield at 6 sites in United Kingdom.
Trial summary
The aim of this research study is to develop a patient decision aid (PDA), and evaluate whether its integration within oncology services enable cancer services to effectively support and provide evidence based resources for women's fertility preservation decisions, following a diagnosis of any cancer type. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Cancer
- How many people
- 98 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- May 2016to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All women of a reproductive age (16yrs+), who have been diagnosed with cancer, and are undergoing or has undergone cancer treatment(s) which may impact fertility will be eligible. The sample of women will be opportunistic and identified from those women referred to the study sites.
Inclusion Criteria: All women aged >16 of a reproductive age, with a diagnosis of any cancer, undergoing cancer treatment(s) which may impact fertility
Exclusion Criteria: Women who have started menopause/ not of a reproductive age
-
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Leeds General Infirmary
Leeds, West Yorkshire, LS1 3EX
Leeds Centre for Reproductive Medicine
Leeds, West Yorkshire, LS14 6UH
St James University Hospital
Leeds, West Yorkshire, LS9 7TF
Jessop Fertility
Sheffield, South Yorkshire, 10 2SF
Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF
Weston Park Hospital Cancer Charity
Sheffield, South Yorkshire, S10 2SJ
About this study
Official title: Development and Evaluation of a Patient Fertility Preservation Decision Aid for Women With Cancer: The Cancer, Fertility and Me Research Study
The aim of this research study is to develop a patient decision aid (PDA), and evaluate whether its integration within oncology services enable cancer services to effectively support and provide evidence based resources for women's fertility preservation decisions, following a diagnosis of any cancer type.
Read the detailed description
Women diagnosed with cancer have to make time-pressured decisions regarding fertility preservation with specialist fertility services whilst planning their cancer treatment with oncology services. Oncologists identify a need for resources enabling them to support women's fertility preservation decisions more effectively; and women report wanting more specialist information to make these choices across service pathways. This research will develop a new evidence-based patient decision aid (PDA) to address this unmet need and evaluate its acceptability to women and services when integrated into usual cancer care pathways at the point of cancer diagnosis and treatment planning.
The objectives are to:
- Develop a PDA for use by oncology teams to support women making fertility preservation choices, whilst having a recent cancer diagnosis.
- Assess the validity of the PDA to support women making informed decisions about fertility preservation before starting their cancer treatment.
- Evaluate the acceptability of the PDA to a) women making fertility preservation decisions whilst planning their cancer treatment and b) oncology and fertility health professionals supporting women's oncology and fertility treatment choices.
This research employs a series of prospective, observational surveys, employing both quantitative and qualitative methods to develop and evaluate the PDA.
Data will be collected during 5 time points:
- Face validity stage- The purpose of this stage is to assess the face validity of the PDA from women and health professionals. Qualitative and quantitative data collection will aim to explore understanding, the purpose of the PDA, and views on its utility.
- Evaluation Stage Baseline- Quantitative data collected from eligible women following their initial treatment planning consultation. Questionnaires are completed prior to reading the PDA.
- Evaluation Stage Time 1- Quantitative data collected from eligible women on arrival to their appointment at the Assisted Conception Unit (ACU). For those women who decide not to attend their appointment with the fertility expert the questionnaires will be either posted or handed to them at their next oncology appointment for completion, at the same time point.
- Evaluation Stage Time 2a- Quantitative data collected from eligible women following completion of their first round of chemotherapy.
- Evaluation Stage Time 2b- Qualitative interview data collected from eligible women following completion of their first round of chemotherapy, and from health professionals.
- Conditions
- Cancer
- Keywords
- Cancer, Fertility Preservation, Patient Decision Aid
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in decisional conflict (Decisional Conflict Scale)
This is a 16-item measure measuring the conflict inherent in the treatment decision encountered. Scores > 37.5 on the overall scale (range 0-100) indicate high decisional conflict, which is characterised by decision delay and/or uncertainty about decision. This will be administered to women.
Measured: Baseline (within 3 days after initial treatment planning consultation); Time 2a- after completion of first round of chemotherapy (within 3 months after reading PDA)
Secondary outcomes (10)
Preparation for Decision Making Scale
This is a 10-item measure which assesses an individual's perception of how useful a DA is in preparing the respondent to communicate with their practitioner at a consultation focused on making a health decision. High scores on the overall scale (range 0-100) indicate higher perceived levels of preparation for decision making. It will be administered to women and health professionals.
Measured: Face validity stage (within one day after reading the PDA)
Change in perception (Preparation for Decision Making Scale)
This is a 10-item measure which assesses an individual's perception of how useful a DA is in preparing the respondent to communicate with their practitioner at a consultation focused on making a health decision. High scores on the overall scale (range 0-100) indicate higher perceived levels of preparation for decision making. This will be administered to women.
Measured: Time 1- the next oncology or fertility consultation (within one month after reading PDA)
Change in decision making readiness (The Stage of Decision Making)
This is a 6 category tool to assess the individual's readiness to engage in decision making, progress in making a choice, and receptivity to considering or re-considering options. Scores are rated 1-6 from not thinking about it at all, to considered options. This will be administered to women.
Measured: Baseline (within 3 days after initial treatment planning consultation); Time 1- the next oncology or fertility consultation (within one month after reading PDA); Time 2a- after completion of first round of chemotherapy (within 3 months after reading PDA)
The Decisional Regret Scale
This is a brief 5-item scale which measures "distress or remorse after a health care decision" using a 5-point Likert scale (1- strongly agree; 5- strongly disagree). A score of 0 on the overall scale (range 0-100) indicates no regret; scores of 100 mean high regret. This will be administered to women.
Measured: Time 2b- after completion of first round of chemotherapy (within 3 months after reading the PDA)
Change in health outcomes (The EQ-5D)
This is a standardised instrument for use as a measure of health outcome. It consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. This will be administered to women.
Measured: Baseline (within 3 days after initial treatment planning consultation); Time 2b- after completion of first round of chemotherapy (within 3 months after reading the PDA)
Change in anxiety (The State Trait Anxiety Inventory)
This is a brief 6-item version used to measure of state anxiety. All items are rated on a 4-point scale (1-Almost never, 4-Almost always). Higher scores indicate greater anxiety. This will be administered to women.
Measured: Baseline (within 3 days after initial treatment planning consultation); Time 1- the next oncology or fertility consultation (within one month after reading PDA); Time 2a- after completion of first round of chemotherapy (within 3 months after reading PDA)
Count Data
Count data will be collected of the number of DAs given to women and clinical staff, counts of use, and number of clicks on the 'Cancer, Fertility and Me' website will be recorded. In addition we will record length of oncology and fertility consultations, and length of time to fertility and cancer treatment.
Measured: Through study completion (an average of 18 months)
Learner Verification Questionnaire
This will consist of 4 items taken from the QQ-10, which is a measure of face validity which has been used in previous studies. The 4 items will be measured on and a 5-point Likert scale (1- strongly agree; 5- strongly disagree). The questionnaire will also comprise of 3 open end questions relating to the acceptability and utility of the PDA from womens and health professionals perspective. This will be administered to women and health professionals.
Measured: Face validity stage (within one day of reading the PDA)
Qualitative Interviews (telephone)
The telephone interview will take place with women and health professionals. The interview schedule will focus Learner Verification (LV) (modified from an existing LV interview schedule) to seek further clarification on answers provided on the questionnaire, and to gain more in-depth information.
Measured: Face validity stage (within 1 week after reading the PDA)
Qualitative Interviews (face to face)
The interview will take place with women. The interview schedule for the face to face interviews will focus on Learner Verification (LV) (modified from an existing LV interview schedule) to explore the PDAs clarity and usefulness in planning care and making decisions between treatment options. Additional areas the interview schedule will focus on include the PDAs likelihood of use, barriers to use in practice, whether or not the women and health professionals benefit from their delivery, usefulness of the PDA in aiding service transition, and how the women used the PDA.
Measured: Time 2b- after completion of first round of chemotherapy (up to 3 months after reading the PDA)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Collaborators
- Yorkshire Cancer Research, Weston Park Hospital Cancer Charity, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield Hallam University, University of Leeds, The Leeds Teaching Hospitals NHS Trust, Breast Cancer Care (Charity), Independent Cancer Patients' Voice (Charity), University of Oxford
- Responsible party
- Principal investigator, Georgina Jones, University of Sheffield
- Investigators
- Georgina L Jones, D.Phil, Principal investigator, Sheffield University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753296
- Sponsor's protocol ID
- 142491
- Status last verified
- Apr 2016
- First submitted
- 16 Apr 2016
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Jones GL, Hughes J, Mahmoodi N, Greenfield D, Brauten-Smith G, Skull J, Gath J, Yeomanson D, Baskind E, Snowden JA, Jacques RM, Velikova G, Collins K, Stark D, Phillips R, Lane S, Bekker HL; (On behalf of the Cancer, Fertility and Me research team). Observational study of the development and evaluation of a fertility preservation patient decision aid for teenage and adult women diagnosed with cancer: the Cancer, Fertility and Me research protocol. BMJ Open. 2017 Mar 13;7(3):e013219. doi: 10.1136/bmjopen-2016-013219.
PubMed 28289046
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Patient Fertility Preservation Decision Aid for Women With Cancer: The Cancer, Fertility and Me Research Study
- ClinicalTrials.gov ID
- NCT02753296
- Acronym / sponsor ID
- 142491
- Conditions
- Cancer
- Keywords
- Cancer, Fertility Preservation, Patient Decision Aid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Collaborators
- Yorkshire Cancer Research, Weston Park Hospital Cancer Charity, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield Hallam University, University of Leeds, The Leeds Teaching Hospitals NHS Trust, Breast Cancer Care (Charity), Independent Cancer Patients' Voice (Charity), University of Oxford
- Study start
- May 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 27 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this research study is to develop a patient decision aid (PDA), and evaluate whether its integration within oncology services enable cancer services to effectively support and provide evidence based resources for women's fertility preservation decisions, following a diagnosis of any cancer type.
Detailed description
Women diagnosed with cancer have to make time-pressured decisions regarding fertility preservation with specialist fertility services whilst planning their cancer treatment with oncology services. Oncologists identify a need for resources enabling them to support women's fertility preservation decisions more effectively; and women report wanting more specialist information to make these choices across service pathways. This research will develop a new evidence-based patient decision aid (PDA) to address this unmet need and evaluate its acceptability to women and services when integrated into usual cancer care pathways at the point of cancer diagnosis and treatment planning.
The objectives are to:
- Develop a PDA for use by oncology teams to support women making fertility preservation choices, whilst having a recent cancer diagnosis.
- Assess the validity of the PDA to support women making informed decisions about fertility preservation before starting their cancer treatment.
- Evaluate the acceptability of the PDA to a) women making fertility preservation decisions whilst planning their cancer treatment and b) oncology and fertility health professionals supporting women's oncology and fertility treatment choices.
This research employs a series of prospective, observational surveys, employing both quantitative and qualitative methods to develop and evaluate the PDA.
Data will be collected during 5 time points:
- Face validity stage- The purpose of this stage is to assess the face validity of the PDA from women and health professionals. Qualitative and quantitative data collection will aim to explore understanding, the purpose of the PDA, and views on its utility.
- Evaluation Stage Baseline- Quantitative data collected from eligible women following their initial treatment planning consultation. Questionnaires are completed prior to reading the PDA.
- Evaluation Stage Time 1- Quantitative data collected from eligible women on arrival to their appointment at the Assisted Conception Unit (ACU). For those women who decide not to attend their appointment with the fertility expert the questionnaires will be either posted or handed to them at their next oncology appointment for completion, at the same time point.
- Evaluation Stage Time 2a- Quantitative data collected from eligible women following completion of their first round of chemotherapy.
- Evaluation Stage Time 2b- Qualitative interview data collected from eligible women following completion of their first round of chemotherapy, and from health professionals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All women of a reproductive age (16yrs+), who have been diagnosed with cancer, and are undergoing or has undergone cancer treatment(s) which may impact fertility will be eligible. The sample of women will be opportunistic and identified from those women referred to the study sites.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in decisional conflict (Decisional Conflict Scale)
Time frame: Baseline (within 3 days after initial treatment planning consultation); Time 2a- after completion of first round of chemotherapy (within 3 months after reading PDA)
This is a 16-item measure measuring the conflict inherent in the treatment decision encountered. Scores > 37.5 on the overall scale (range 0-100) indicate high decisional conflict, which is characterised by decision delay and/or uncertainty about decision. This will be administered to women.
10 secondary outcomes
Preparation for Decision Making Scale
Time frame: Face validity stage (within one day after reading the PDA)
Change in perception (Preparation for Decision Making Scale)
Time frame: Time 1- the next oncology or fertility consultation (within one month after reading PDA)
Change in decision making readiness (The Stage of Decision Making)
Time frame: Baseline (within 3 days after initial treatment planning consultation); Time 1- the next oncology or fertility consultation (within one month after reading PDA); Time 2a- after completion of first round of chemotherapy (within 3 months after reading PDA)
The Decisional Regret Scale
Time frame: Time 2b- after completion of first round of chemotherapy (within 3 months after reading the PDA)
Change in health outcomes (The EQ-5D)
Time frame: Baseline (within 3 days after initial treatment planning consultation); Time 2b- after completion of first round of chemotherapy (within 3 months after reading the PDA)
Change in anxiety (The State Trait Anxiety Inventory)
Time frame: Baseline (within 3 days after initial treatment planning consultation); Time 1- the next oncology or fertility consultation (within one month after reading PDA); Time 2a- after completion of first round of chemotherapy (within 3 months after reading PDA)
Count Data
Time frame: Through study completion (an average of 18 months)
Learner Verification Questionnaire
Time frame: Face validity stage (within one day of reading the PDA)
Qualitative Interviews (telephone)
Time frame: Face validity stage (within 1 week after reading the PDA)
Qualitative Interviews (face to face)
Time frame: Time 2b- after completion of first round of chemotherapy (up to 3 months after reading the PDA)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
- Derived from this study: PubMed 28289046Jones GL, Hughes J, Mahmoodi N, Greenfield D, Brauten-Smith G, Skull J, Gath J, Yeomanson D, Baskind E, Snowden JA, Jacques RM, Velikova G, Collins K, Stark D, Phillips R, Lane S, Bekker HL; (On behalf of the Cancer, Fertility and Me research team). Observational study of the development and evaluation of a fertility preservation patient decision aid for teenage and adult women diagnosed with cancer: the Cancer, Fertility and Me research protocol. BMJ Open. 2017 Mar 13;7(3):e013219. doi: 10.1136/bmjopen-2016-013219.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgina L Jones, D.Phil principal investigator
Sheffield University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University of Sheffield at 6 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georgina L Jones, D.Phil (0114 222 0806, g.l.jones@sheffield.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in decisional conflict (Decisional Conflict Scale) (time frame: Baseline (within 3 days after initial treatment planning consultation); Time 2a- after completion of first round of chemotherapy (within 3 months after reading PDA)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02753296, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2016.